52 Senior Medical Writer (56025) Jobs in Boston, MA
SORT BY
C
P
C
P
P
S
S
R
R
P
S
M
W
C
C
A
B
m
X
G
B
M
O
L
L
A
Senior Medical Writer (56025)
$90k-108k (estimate)
Full Time | Pharmaceutical
1 Week Ago
Praxis Precision Medicines is Hiring a Senior Medical Writer (56025) Near Boston, MA
Job DetailsJob Location
Remote - Boston, MA
Remote Type
Fully Remote
Position Type
Full Time
Education Level
4 Year Degree
Travel Percentage
Minimum of 2x/year to Boston area
Job Category
Biotech
DescriptionPosition SummaryAs a Medical Writer at Praxis you'll use your abilities to provide complete, accurate, high quality, and compliant documents in support of our clinical trials and regulatory submissions. You'll apply your knowledge and expertise to collaboratively author required documents with support from the Associate Director of Medical Writing while also helping teams follow medical writing processes and style requirements. If the job sounds like a fit for you, we look forward to receiving and reviewing your application.
Primary Responsibilities
Company OverviewPraxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion Guided by our core values, we continue to DARE FOR MORE™ to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to .
Remote - Boston, MA
Remote Type
Fully Remote
Position Type
Full Time
Education Level
4 Year Degree
Travel Percentage
Minimum of 2x/year to Boston area
Job Category
Biotech
DescriptionPosition SummaryAs a Medical Writer at Praxis you'll use your abilities to provide complete, accurate, high quality, and compliant documents in support of our clinical trials and regulatory submissions. You'll apply your knowledge and expertise to collaboratively author required documents with support from the Associate Director of Medical Writing while also helping teams follow medical writing processes and style requirements. If the job sounds like a fit for you, we look forward to receiving and reviewing your application.
Primary Responsibilities
- Implements all activities related to the preparation of defined medical and regulatory documents, serving as writing lead on assigned documents or identifying when external writers are necessary for support
- Supports documents for regulatory submissions to US and global health authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), protocols, investigator brochures, clinical study reports, briefing documents, regulatory responses to health authority questions, and scheduled reports
- Collaborates with cross-functional team members, eg, Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostats, Data Management, Quality, CMC, QC, etc., to ensure accurate and timely completion and delivery of high-quality, scientifically-sound documents, slide decks, and publications
- Supports clinical trial transparency and disclosures, including clinical trials registration and results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide
- Contributes to departmental development through editorial and review support for document templates, style standards, reviewer guidelines, and standard operating procedures to ensure consistent and high-quality deliverables
- Ensures adherence to relevant SOPs and internal best practices
- Bachelor’s degree required within a scientific discipline. Advanced degree, CNS, and Rare Disease experience a plus
- 4 years of medical writing experience in Sponsor or CRO setting
- AMWA certification preferred
- Experience using medical writing systems and technologies including Veeva RIM
- Knowledge of drug development, study conduct processes, ICH guidelines, and FDA/EU guidance or demonstrated success within a regulated industry environment
- Highly organized and detail-oriented with a passion to deliver quality results quickly
- Strong verbal and written communication skills with an ability to build relationships internally and externally
- Highest levels of professionalism, confidence, personal values, and ethical standards
- 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
- Bonus program structured to pay on a quarterly basis
- 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
- Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, spa services, student loan repayment, sports fees and much more
- Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
- Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)
Company OverviewPraxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion Guided by our core values, we continue to DARE FOR MORE™ to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to .
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$90k-108k (estimate)
POST DATE
06/20/2024
EXPIRATION DATE
07/17/2024
WEBSITE
praxismedicines.com
HEADQUARTERS
KENDALL SQUARE, MA
SIZE
50 - 100
FOUNDED
2016
CEO
MARCIO SOUZA
REVENUE
$10M - $50M
INDUSTRY
Pharmaceutical
Related Companies
Show more
The job skills required for Senior Medical Writer (56025) include Medical Writing, Clinical Research, Clinical Trial, Drug Development, Written Communication, SOP, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Medical Writer (56025). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Medical Writer (56025). Select any job title you are interested in and start to search job requirements.
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
